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Completed

NCT Number: NCT04254614

Mobile Application for IBD Patients With Biologics

Monitoring of biologic treatment in patients with inflammatory bowel disease (IBD) is important given the increased risk of infections. In this study we aim to evaluate the use of a mobile application to guide IBD patients and facilitate the monitoring of biologic treatment.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

About this study

Biologic treatment can induce and maintain remission in patients with inflammatory bowel disease (IBD). However, biologics are associated with increased risk of infections. Therefore, it is important to regularly monitor patients during the course of therapy. This process can be time consuming for patients as well as clinicians. Mobile applications, have the potential to guide patients and facilitate monitoring of biologic treatment. In this study we aim to evaluate the use of a mobile application to guide IBD patients during biologic treatment. Adult patients with diagnosis of IBD treated with biologics will be included. The mobile application with personalised content will give patients information about their treatment, reminders for example when blood tests and questionnaires to check for adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of inflammatory bowel disease
  • Treatment with infliximab or vedolizumab
  • Ability to read and understand Dutch language

Exclusion criteria

  • Patients recently started with biologic treatment

Treatment and study plan

Personalised mobile application for IBD patients

Device

Patients will use a mobile application for ±6months (exact period depends on interval of biologic treatment) with the following functionalities:

  • Personal interactive timeline to prepare for biologic treatment with reminders for blood tests, a questionnaire to exclude contra-indications for biologic treatment (e.g. current infection) and a message from the gastroenterology nurse when blood tests results and the questionnaire have been checked. Only in case of abnormal results or answers patients will be contacted by telephone by their gastroenterology nurse, which is currently standard care.
  • Information about the patients' diagnosis and biologic treatment.
  • General information on e.g. IBD treatment, vaccinations, frequently used medical terms, preparing for outpatient visits, what to do in case of disease symptoms.

Patients will fill in a questionnaire to measure study outcomes at baseline and at the end of the study period.

Primary outcomes

  1. Patient satisfaction

    Time frame: 6 months

    All patients will be asked to complete questions about satisfaction with the mobile application, the information in the app and the user-friendliness of the app. This will be measured with a 7-point likert scale after using the application for ± 6 months. We will also ask patients about their overall satisfaction of care before and after implementation of the application using a visual analogue scale (VAS) scale 0 - 10.

  2. Actual use - frequency

    Time frame: 6 months

    Use will be monitored with log data of the application. We will look at frequency of use of the application.

  3. Adherence

    Time frame: 6 months

    The adherence of patients to reminders will be evaluated by checking time of blood tests as recorded in the electronic medical record and log data from administered questionnaires.

Secondary outcomes

  1. Satisfaction of care providers

    Time frame: 6 months

    After ± 6 months, health care professionals will be asked to fill in a questionnaire to measure their experiences with the application, experience with monitoring the questionnaire, satisfaction, organizational advantages/disadvantages for example time investment, efficiency of work processes. This will be measured with a 7-point likert scale after using the application for ± 6 months. We will also ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10.

  2. Overall satisfaction of care providers

    Time frame: 6 months

    We will ask care providers about their overall satisfaction with the application using a VAS scale 0 - 10.

  3. Number of outpatient visits

    Time frame: 6 months

    The total number of outpatients visits in the six months before and after implementation of the application will be compared.

  4. Number of telephone contacts

    Time frame: 6 months

    The total number of telephone contacts in the six months before and after implementation of the application will be compared.

  5. Disease and treatment knowledge

    Time frame: 6 months

    The knowledge of disease and its treatment of patients before and after implementation of the application will be compared and assessed using a VAS Scale (scale 0 - 10).

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

A Mobile Application Guiding Patients With Inflammatory Bowel Disease During Biologic Treatment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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